Thursday, April 17, 2014

BIO Mimics PhRMA's Comments to FDA Regarding Recent SM Guidance But Is More Polite About It

In its opening remarks in comments submitted to the FDA regarding recent Draft Guidance ("Guidance for Industry: Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics"), the Biotechnology Industry Organization (BIO) thanks the agency for acknowledging the "unique characteristics and logistical considerations presented by content available through the internet and social media... Because of the uniqueness and rapid evolution of this media," said BIO, "it is important to apply flexibility in the regulatory approach to enable companies to participate more fully and develop responsible policies and practices to help advance and encourage the safe use of their products."

PhRMA, on the other hand dives right into criticism of the agency (read "PhRMA Questions Legality of FDA's Recent Social Media Guidance") and only thanks the FDA for its efforts, lousy though they may be, in its closing paragraph!

BIO mimics many of PhRMA's criticisms such as calling on the FDA to align the Draft Guidance more closely to the law; i.e., Federal Food, Drug and Cosmetic Act (FFDCA).

"As a predicate matter," said BIO, "when FDA considers the final guidance and future guidances, the Agency should clarify that the appropriate definition of 'labeling' is found in 21 U.S.C. §21(m), the general regulatory definition of labeling in 21 C.F.R. 1.3(a), and relevant case law" (including Kordel vs. United States; see here).

So, like PhRMA, BIO is taking FDA to school about regulatory law. BIO, however, couches its criticism as a debate ("predicate matter") whereas PhRMA invokes legal consequences: "a significant chill on First-Amendment-protected speech."

BIO and PhRMA also agree that the "Influence Test" in the Draft Guidance is a problem. Unlike PhRMA and Novartis, which both recommend trashing the "influence Test," BIO suggests more clarification is needed with regard whether or not the content is subject to FDA regulation in the first place, regardless of the "influence: over third parties.

"We believe that this position is overly broad and subject to misinterpretation regarding the scope of FDA’s regulatory authority over labeling and advertising," said BIO. BIO "requested" that the Draft Guidance be revised to "clarify that not all communications or information by a firm or its employees are labeling or advertising."

BIO also "requested" that the Draft Guidance be "revised to clarify that not all communications or information by a firm or its employees are labeling or advertising." Scientific exchange of UGC, for example should not be regulated by the FDA according to BIO:
"Additional examples of firm activities that should not be viewed as labeling or advertising include providing a forum for the scientific exchange of UGC, informing a third party of inaccurate medical or scientific information about a product, or preventing the posting of inaccurate information."
I suspect BIO is thinking about "inaccurate information" on Wikipedia (the epitome of UGC). I covered this topic recently in Pharma Marketing News (read "Right & Wrong Ways for Pharma to Correct Misinformation on Wikipedia"). BIO has more to say on that subject, which is more evidence that Wikipedia is top of mind here:
"Specifically, activities by a firm or its employees that are not viewed as labeling or advertising should include situations where a firm merely corrects a third party’s inaccurate information about the firm’s products, or prevents such inaccurate information from being posted in the first instance. Although firms are not (and should not be) required to monitor or seek to correct internet content not created or controlled by them, there may be instances in which a firm may seek to correct inaccurate information on interactive promotional media of which the firm becomes aware. This should not be viewed as “influence” over the content that would subject that content to labeling or advertising requirements."
According to BIO, some financial support and editorial review by firms are so minimal as to not be "influential":
"The Draft Guidance should be revised to acknowledge situations where a firm can provide more than just 'financial support' and yet the firm’s influence is so limited in scope that it should not be viewed as accountable for the content such that the communication or information might be considered labeling or advertising. For example, a firm may provide general guidelines to a third party for its appropriate content development within the third party contract, or maintain some rights to review (but not alter) the content and should therefore not have the information or communication be considered labeling or advertising."
I don't know about you, but I appreciate even small gifts although many physicians think it insulting to believe such small gifts influence their prescribing habits (research indicates otherwise; read "The Slippery Slope of Pharma Physician Phreebies").

"Firms should not be responsible for promotional labeling when they merely have the ability to 'preview' or 'review' content on a third-party site," said BIO. "The mere fact of having preview or review privileges does not necessarily equate to influence over content."

As a blogger, I am grateful that I have no obligation to submit my copy to anyone for "review" before publishing. Imagine a patient blogger supported by a small financial grant from a pharma company that also invokes the right to review blog posts before publication. Regardless as to how "limited in scope" that may be, I think it is influential and is definitely "a significant chill on First-Amendment-protected speech."

I think I covered the major concerns that BIO has with the Draft Guidance. I'm attempting to get a copy of Pfizer's comments from which I can copy text for purposes of review. The document that Pfizer submitted is a scanned image of printed pages. It's fuzzy and difficult or impossible to copy. Not a good model of transparency as far as I am concerned. Oh well!

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